Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth

NCT ID: NCT03526276

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-10-31

Brief Summary

This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence (QLF) system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.

Detailed Description

Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.

Materials and Methods:

o Study design:

The present study is a randomized control trial (RCT).

• Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
• Study procedure:

• Study population includes healthy children (n=118) aged between 4-5 years diagnosed with white spot lesions.
• Oral examination at baseline to record dmft and caries risk using the Caries-risk Assessment Tool (CAT) based on American Academy of Pediatric Dentistry (AAPD) guidelines will be carried out, patients will be classified as: low, moderate or high risk
• Quantitative assessment of early caries lesions will be carried out using QLF.
• Children will be randomly allocated into three groups:

Group 1: children will brush their teeth with CPP-ACP twice daily.

Group 2: children will brush their teeth with fluoridated toothpaste twice daily.

Group 3: children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

The researcher will do the morning application at school, the evening application will be done at home with help of the parent. The researcher will give oral hygiene and brushing instructions to the parents and also diet advice. An oral hygiene chart will be given to monitor twice-daily tooth brushing.

Conditions

White Spot Lesion of Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPP-ACP paste

Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.

Group Type: ACTIVE_COMPARATOR

CPP-ACP paste

Intervention Type: OTHER

Children will brush their teeth with CPP-ACP paste twice daily.

Fluoride toothpaste

Fluoride toothpaste

Group Type: ACTIVE_COMPARATOR

Fluoride toothpaste

Intervention Type: OTHER

Children will brush their teeth with fluoridated toothpaste twice daily

Both (Fluoride and CPP-ACP)

Fluoride toothpaste and CPP-ACP paste

Group Type: ACTIVE_COMPARATOR

Both (Fluoride and CPP-ACP)

Intervention Type: OTHER

Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.

Interventions

CPP-ACP paste

Children will brush their teeth with CPP-ACP paste twice daily.

Intervention Type: OTHER

Fluoride toothpaste

Children will brush their teeth with fluoridated toothpaste twice daily

Intervention Type: OTHER

Both (Fluoride and CPP-ACP)

Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy 4-5 years old children, with primary dentition, and early white spot lesions

Exclusion Criteria

• Lack of cooperation in the oral examination.
• Allergies to milk protein.
• Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
• Medically compromised patient.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scientific Research Fund, Ministry of Higher Education and Research, Jordan

UNKNOWN

Sponsor Role: collaborator

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ola Al-Batayneh, MDSc, FRACDS

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology

Irbid, , Jordan

Countries

Jordan

Other Identifiers

284-2015

Identifier Type: -

Identifier Source: org_study_id